Minimizing risk in health technology innovation: A checklist

The process of medical device innovation is quite complex. First, innovators must pick the right problem to solve, not an easy task. Then, they have to develop a solution that is compelling enough to get all of the decision-makers in health care – including doctors, patients, facilities, regulators, and payers – to support it.

It's also a high-stakes endeavor. "It can take 5 to 7 years and upwards of $80 million to bring a new medical technology to market,” says Uday Kumar, MD, director of strategy at the Stanford Byers Center for Biodesign. "That's why it's important for innovators to de-risk their ideas early."

To meet these challenges, the doctors and engineers in the Biodesign Innovation Fellowship program spend nearly a year working to understand and prioritize the problems they observe, invent devices and figure out how to bring those solutions to patients. With the help of instructors and mentors, they screen their options at each step along the way. Are enough people affected by this problem? How much potential is there to improve care or save money? This filtering process helps ensure that the strongest possibilities advance, while those that have more risks drop away.

This year the fellows, who have been focusing on problems related to aging and longevity, started by observing hundreds of unmet needs in areas such as heart failure, glaucoma and osteoarthritis. After filtering their lists down to two or three top needs, they are ready to start building prototypes of device solutions. To help them choose solutions with the lowest risk and highest probability of success, Kumar, who is an alumnus of the Innovation Fellowship and the founder of the Biodesign-originated company iRhythm Technologies, Inc. (IRTC), asks the teams to consider the following questions:

Are you focused on an important unmet clinical need? “This question is first posed early on, when the fellows complete their needs finding,” Kumar said. “But it’s important to go back and be certain that others in health care agree that this problem is worth addressing.”

Do you have a new solution? “The solution has to solve the need really well, be technically feasible and have patentable intellectual property,” Kumar said.

Do you understand the regulatory pathway? In the United States, all medical devices are regulated by the Food and Drug Administration. Inventors need to consider whether their invention will qualify for a quicker and less expensive regulatory pathway because a similar device exists, or if the path will be longer because their solution is more unique. “Innovators also need to think about the amount of clinical evidence they will need to demonstrate safety, performance and/or efficacy,” Kumar said.

Do you understand the reimbursement pathway? “Getting a new technology reimbursed by government or private insurers is a complex process,” Kumar said. “Does the team need to demonstrate certain clinical or cost-sparing outcomes first? And will the reimbursement be sufficient to interest the investors needed to fund the company?”

Do you have corporate alignment? Most startups hope to eventually be acquired by larger medtech firms. However, this requires a fit between your technology and their clinical areas of interest.

Do you have a global strategy? With the large medtech companies increasingly interested in expanding their global footprint, the question of whether the solution could meet needs in emerging markets with vast patient populations is important to consider.

“Finally, after answering these questions, the fellows need to think about how personally ready they are to tackle this project,” Kumar said. “A certain part of the decision about whether to take a technology forward involves evaluating where you are in your life, how passionate you feel and what you are able and willing to take on.”